NCT06846489

Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma

Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma: A Single-Arm, Open-Label, Multicenter, Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single- arm, open-label, multicenter, phase II study to evaluate Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma

Detailed description

The purpose of this study is to evaluate the efficacy and safety of Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma Treatrment: 1. Acalabrutinib: 100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment 2. Rituximab: 375 mg/m2 IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months. The primary study endpoint is the investigator-assessed complete response (CR) rate at 12 months.

Conditions

• Mantle Cell Lymphoma (MCL)

Interventions

Type	Name	Description
DRUG	Acalabrutinib	100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment.
DRUG	Rituximab	375 mg/m² IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months

Timeline

• Start date: 2025-04-14
• Primary completion: 2033-02-10
• Completion: 2033-02-20
• First posted: 2025-02-26
• Last updated: 2025-06-03

Locations

1 site across 1 country: China